Food and Drug Regulations
C.04.128 Poliovirus Vaccine, Live, Oral or Poliovirus Vaccine, Live, Oral (Naming the strains) shall be prepared from living poliomyelitis virus types I, II and III that
(a) have been obtained directly from a source acceptable to the Director;
(b) are shown to be genetically stable by an acceptable method;
(c) are shown to be non-pathogenic when given orally to humans;
(d) are proved to be capable of multiplying in the human alimentary tract and of producing type specific neutralizing antibodies when administered orally; and
(e) have a history of successful use in the production of polio-virus vaccine, live, oral.
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